Maria Alexis Bent
Medical Devices Intern @Global Regulatory Writing & Consulting (GLOBAL)
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WORK HISTORY
Medical Devices Intern @Global Regulatory Writing & Consulting (GLOBAL)
Author of 14 and coauthor of 11 regulatory documents for class and IIb medical devices on the EU market. • Manage and author of LSP, LSR, CEP, and PMCF report. • Coauthor of PSUR, CER, SOA, and SSCP.• Summarize relevant safety and performance data from clinical, preclinical, and case reports for the CER.• Execute literature searches, screening, and extractions for subject & competitor devices and SOA for the CER.• Analyze sales and complaint data, as well as adverse event databases, to identify potential new harms for the PSUR. • Collaborate with coworkers in a virtual environment, resulting in the timely execution of project deliverables.• Routinely perform quality checks to ensure information is accurate and up to standards. • Knowledgeable of Excel and Word formatting techniques to improve deliverable formatting and accuracy.
EDUCATION
Virginia Commonwealth University
Doctor of Philosophy - PhD, Neuroscience
University of North Carolina Wilmington
Bachelor of Science - BS
SKILLS
ABOUT MARIA ALEXIS BENT
Regulatory medical writer for medical devices experienced in MDD-compliant and…
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